BMS SWORDS API MANUFACTURING SITE AUTOMATION STRATEGY - DEVELOPMENT & INTEGRATION

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1 BMS SWORDS API MANUFACTURING SITE AUTOMATION STRATEGY - DEVELOPMENT & INTEGRATION AIDAN DESMOND DIRECTOR, AUTOMATION & IT API OPERATIONS & EXTERNAL MANUFACTURING

2 AGENDA 1. BMS OVERVIEW ORGANISATIONAL OUTLINE & SWORDS SITE 2. PLANT 8 (P8) DELTA V UPGRADE CASE STUDY 3. AUTOMATION STRATEGY DEVELOPMENT & INTEGRATION 4. SUMMARY

3 AGENDA 1. BMS OVERVIEW ORGANISATIONAL OUTLINE & SWORDS SITE 2. PLANT 8 (P8) DELTA V UPGRADE CASE STUDY 3. AUTOMATION STRATEGY DEVELOPMENT & INTEGRATION 4. SUMMARY

4 BRISTOL-MYERS SQUIBB To discover, develop and deliver innovative medicines that help patients prevail over serious diseases. A heritage more than 158 years strong, founded in Headquarters located in New York, U.S.A. Approx. 24,000 employees worldwide Net Sales - $15.9 billion in 2014 R&D Investment - $4.5 billion in 2014 Global Manufacturing & Supply

5 BMS IRELAND OPERATIONS Swords API Manufacturing External Manufacturing Blanchardstown Cruiserath Biologics Manufacturing (Under Construction) External Manufacturing Distribution Cntr, Shannon

6 SWORDS API OPERATIONS Bulk Active Pharmaceutical Ingredient manufacturing facility. One of the first pharmaceutical companies to begin manufacturing in Ireland. The site was inaugurated in There are 6 separate manufacturing plants, a thermal oxidiser and a waste water treatment plant on the Swords site. Swords Laboratories currently manufactures multiple APIs and Intermediates.

7 AGENDA 1. BMS OVERVIEW ORGANISATIONAL OUTLINE & SWORDS SITE 2. PLANT 8 (P8) DELTA V UPGRADE CASE STUDY 3. AUTOMATION STRATEGY DEVELOPMENT & INTEGRATION 4. SUMMARY

8 A STAGE OF SITE STRATEGY A JOURNEY TO BENCHMARK CAPITAL PROJECT TO REPLACE END OF LIFE ABB DCS WITH DELTA V DCS

9 WHY IMPLEMENT A NEW DCS? THE BUSINESS DRIVERS Support & Maintenance End of Life System Replaced Integration into Site Wide System End of Life Instruments Replaced Leverage Corporate Standards & Support Agreements Standardised Spares Safety Enhance Operator Interface Full Alarm & Interlock Re-design Engineering Standards Increased Automation Future Proofing & Integration Separation of Key Site Wide Utilities from P8 Control System Capacity for Growth Expansion MES Integration Capability ebatch Record Capability Recipe Control Compliance Improved Data Collection Redundancy Fewer Deviations Better Temperature Control Full Suite of Validation

10 SCHEDULE IMPACT MINIMISED PLANT DOWN TIME P8 Shutdown for 13 weeks 2 Additional Plant Shutdown for 4 weeks P3 & P9 - end users of Syltherm / Glycol which was controlled from the P8 ABB DCS Multi-departmental contribution Maintenance, Engineering, Manufacturing, Quality, Automation, EHS 4,000 Construction Man Hours 13,000 Engineering Man Hours 24/7 Commissioning with Plant Personnel Over 500 Maintenance Work Orders 29 km cable installed in 10 weeks 1800 I/O s Zero Lost Time Accidents

11 IMPLEMENTED USING IN-HOUSE CAPABILITY Cost Effective solution utilising in house resources Expertise retained within the Automation Team and other supporting departments Improved on going support support team involved in project Desired end product delivered scoped, developed and delivered by in house project team Ultimate Flexibility our resources drove the project based on site needs

12 AGENDA 1. BMS OVERVIEW ORGANISATIONAL OUTLINE & SWORDS SITE 2. PLANT 8 (P8) DELTA V UPGRADE CASE STUDY 3. AUTOMATION STRATEGY DEVELOPMENT & INTEGRATION 4. SUMMARY

13 AUTOMATION STRATEGY DEVELOPMENT Why What are the business drivers? Support & Maintenance Future Proofing & Integration Safety Compliance/Quality Vision Agility Robustness Simplification

14 AUTOMATION STRATEGY DEVELOPMENT Why What Agility - we will accelerate production delivery speed by: Designing automated systems to optimize tech transfer time Enhancing production scheduling capability Robustness - we will increase equipment robustness by: Responding faster to errors and proactively eliminating risks Designing human error out of the manufacturing process Simplification - We will simplify work processes by: Making people's jobs easier and simpler Enabling electronic documentation and reporting by exception

15 AUTOMATION STRATEGY DEVELOPMENT Why What Program of work established and managed under Site PMO Collaborative cross departmental team established with key involvement from Engineering & Manufacturing End User Requirements driven by the Business not Automation this is a business initiative not technical Key element to overall Site Master Strategy Key focus on forward looking manufacturing schedule and the changing dynamic for the site How Combined effort with Lab Automation Strategy

16 AUTOMATION STRATEGY - INTEGRATION We have all the key ingredients Focus on greater utilisation of systems IT Strategy SAP Integration Maximo Integration SAP Feasibility Study Mobility & RFID Warehouse Plants Labs Historian Integration Automation Strategy QMS Integration (Trackwise) Maximo driving Product Robustness IT/Automation engagement Model MES Strategy Syncade Lab Automation Strategy DCS Integration MES Deployment Lab Automation Strategy Instrument Replacement Program SmartLab/eLN Empower3 - Chrome NuGenesis Non - Chrome OpenLab

17 AGENDA 1. BMS OVERVIEW ORGANISATIONAL OUTLINE & SWORDS SITE 2. PLANT 8 (P8) DELTA V UPGRADE CASE STUDY 3. AUTOMATION STRATEGY DEVELOPMENT & INTEGRATION 4. SUMMARY

18 SUMMARY Foundations are being put in place - Key systems implemented Recognition of the need to drive greater automation to support the site Core capabilities developed within the Automation Team, Manufacturing, Engineering and Quality Automation roadmap being developed based on the evolving needs of the site business drive FDA Data Integrity Focus

19 THANK YOU

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